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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05404880
Other study ID # 2021-09
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 13, 2022
Est. completion date December 2029

Study information

Verified date March 2024
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.


Description:

The trial is a multi-center, prospective, single-arm study that will enroll up to 250 subjects. The study is being divided into 2 stages: Stage 1 is enrollment and 5 years of follow-up after implantation. Stage 2 is additional follow-up through 10 years upon authority's feedback if needed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 255
Est. completion date December 2029
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject is 18 years or older 2. Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU 3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement 4. Provide signed informed consent prior to the study participation Exclusion Criteria: 1. Valve implantation is contraindicated per the IFU 2. Requires planned multiple valve replacement/ repair 3. Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery 4. Estimated Life expectancy< 12 months 5. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

Study Design


Related Conditions & MeSH terms


Intervention

Device:
EDWARDS INSPIRIS RESILIA Aortic Valve
Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.

Locations

Country Name City State
China Beijing Anzhen Hospital, Capital Medical University Beijing Beijing
China Fuwai Hospital, CAMS & PUMC Beijing Beijing
China Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital Chengdu Sichuan
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China The First Affiliated Hospital of USTC (Anhui Provincial Hospital) Hefei Anhui
China Fuwai Yunnan Cardiovascular Hospital Kunming Yunnan
China Nanjing First Hospital Nanjing Jiangsu
China Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen Shenzhen Guangdong
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Xiamen Cardiovascular Hospital Xiamen University Xiamen Fujian
China Fuwai Central China Cardiovascular Hospital Zhengzhou Henan
China Henan Provincial Chest Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (4)

Lead Sponsor Collaborator
Edwards Lifesciences Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd., Fuwai Hospital, CAMS & PUMC, Rundo International Pharmaceutical Research & Development Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject's Occurrence Rate of Study Valve Related Death The primary safety endpoint is the percentage of study valve related death which includes death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death. 5 Years
Primary Subject's Occurrence Rate of Structural Valve Deterioration The primary safety endpoint is the percentage of Structural Valve Deterioration which includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by re-operation, autopsy, or clinical investigation. 5 Years
Primary Subject's Occurrence Rate of Re-operation on the Study Valve The primary safety endpoint is the reoperation rate on the study valve which is any operation that repairs, alters, or replaces the study valve, which occurs after the completion of the procedure and the transfer out of the procedure room. 5 Years
Primary Subject's Occurrence Rate of Major Bleeding The primary safety endpoint is the rate of major bleeding which is any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. Vision loss) or necessitates transfusion of 3 or more units of PRBC, pericardiocentesis, or exploration/reoperation for bleeding. 5 Years
Primary Subject's Occurrence Rate of Thromboembolic Events The primary safety endpoint is the rate of thromboembolic events which is an embolic event that occurs in absence of infection (endocarditis) starting from anesthesia time. Embolism may be manifested by a neurologic event (Stroke or Transient Ischemic Attack) or a non-cerebral embolic event. 5 Years
Primary Subject's Occurrence Rate of Stroke The primary safety endpoint is the rate of strokes which is a prolonged (>72 hours) or permanent neurologic deficit that is usually associated with abnormal results of magnetic resonance imaging or computed tomographic scans. 5 Years
Primary Subject's Occurrence Rate of Transient Ischemic Attack The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration. 5 Years
Primary Subject's Occurrence Rate of Non-Cerebral Thromboembolism The primary safety endpoint is the rate of non-cerebral thromboembolism which is an embolus documented operatively, at autopsy, or clinically that produces signs or symptoms attributable to complete or partial obstruction of a peripheral artery (does not include deep vein thrombosis). 5 Years
Secondary Subject's Average Mean Gradient at 5 Years Hemodynamic performance - Mean gradients as evaluated by echocardiography 5 Years
Secondary Subject's Average Peak Gradient at 5 Years Hemodynamic performance - Peak gradients as evaluated by echocardiography 5 Years
Secondary Subject's Average Effective Orifice Area at 5 Years Hemodynamic performance - Effective Orifice Area evaluated by echocardiography 5 Years
Secondary Subject's Average Effective Orifice Area Index at 5 Years Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography 5 Years
Secondary Amount of Aortic Central Regurgitation in Subjects at 5 Years Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography 5 Years
Secondary Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography 5 Years
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